Core Viewpoint - Medicus Pharma has completed patient enrollment in its SkinJect clinical trial, marking a significant milestone in the development of a noninvasive treatment for basal cell carcinoma, the most common skin cancer [1][4]. Company Overview - Medicus Pharma is advancing its clinical development program for SkinJect, a novel treatment targeting non-melanoma skin diseases, particularly basal cell carcinoma [3][4]. - The company has been working on this project since the fall of 2023, with patient recruitment starting in August 2024 [4]. Clinical Trial Details - The clinical trial has enrolled 90 patients across nine sites in the United States [1][4]. - The company aims to present topline data in Q1 2026 and plans to sync with the FDA for an end-of-phase-two meeting in the first half of next year [4][8]. Treatment Methodology - SkinJect utilizes uniquely designed microneedle arrays developed from Carnegie Mellon and the University of Pittsburgh, allowing for direct application of a chemotherapeutic agent, doxorubicin, to the cancer site [6]. - This method is intended to trigger an immunogenic response and effectively kill cancer cells [6]. Market Context - Non-melanoma skin diseases, especially basal cell carcinoma, account for 5 million new cases annually in the United States and over 30 million globally [5]. - Traditional treatments like Mohs surgery are expensive and painful, highlighting the need for a more cost-effective and aesthetically pleasing alternative [5][7]. Future Outlook - The company is optimistic about the upcoming topline data and the potential for a Priority Review Voucher from the FDA, which could expedite the new drug application timeline by 10-12 months [8][9]. - The NDA is expected to be filed in late 2027 or early 2028, aligning with the company's positive momentum [8][9].
Medicus Pharma completes SkinJect trial enrolment – ICYMI